EN ISO 14630:2008

Non-active surgical implants - General requirements (ISO 14630:2008)

This International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. This International Standard is not applicable to dentalimplants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue. With regard to safety, this International Standard gives requirements for intended performance,design attributes, materials, design evaluation, manilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.

Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2008)

Diese Internationale Norm legt allgemeine Anforderungen für nichtaktive chirurgische Implantate fest, im Folgenden Implantate genannt. Diese Internationale Norm gilt nicht für Dentalimplantate, dentalrestaurative Werkstoffe, transendodontische und transradikuläre Implantate, Intraokularlinsen sowie Implantate, die lebensfähige tierische Gewebe nutzen.
In Bezug auf die Sicherheit legt diese Internationale Norm Anforderungen für die beabsichtigte Funktion, Konstruktions¬merkmale, Werkstoffe, Designprüfung, Herstellung, Sterilisation, Verpackung und die Bereitstellung von Informationen durch den Hersteller sowie Prüfverfahren fest, um die Übereinstimmung mit diesen Anforderungen zu zeigen. Zusätzliche Prüfverfahren sind enthalten in Normen der Ebene 2 und 3 bzw. es finden sich darin Verweise hierauf.
ANMERKUNG   Diese Internationale Norm fordert vom Hersteller kein Qualitätsmanagementsystem. Dennoch könnte die Anwendung eines wie in ISO 13485 beschriebenen Qualitätsmanagementsystems zur Unterstützung der Gewähr¬leistung angemessen sein, dass das Implantat die beabsichtigte Funktion erfüllt.

Implants chirurgicaux non actifs - Exigences générales (ISO 14630:2008)

Neaktivni kirurški vsadki (implantati) - Splošne zahteve (ISO 14630:2008)

General Information

• Status: Withdrawn
• Publication Date: 14-Jan-2008
• Withdrawal Date: 12-May-2009
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: CEN/TC 285 - Non-active surgical implants
• Drafting Committee: CEN/TC 285/WG 1 - General requirements for non active surgical implants
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 13-May-2009
• Completion Date: 13-May-2009
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 14630:2008 - Non-active surgical implants - General requirements (ISO 14630:2008)

Relations

• Replaces: EN ISO 14630:2005 - Non-active surgical implants - General requirements (ISO 14630:2005)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 14630:2009 - Non-active surgical implants - General requirements (ISO 14630:2008)
• Effective Date: 20-May-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 14630:2008
01-marec-2008
1DGRPHãþD
SIST EN ISO 14630:2005
Neaktivni kirurški vsadki (implantati) - Splošne zahteve (ISO 14630:2008)
Non-active surgical implants - General requirements (ISO 14630:2008)
Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2008)
Implants chirurgicaux non actifs - Exigences générales (ISO 14630:2008)
Ta slovenski standard je istoveten z: EN ISO 14630:2008
ICS:
11.040.40
SIST EN ISO 14630:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 14630
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2008
ICS 11.040.40 Supersedes EN ISO 14630:2005
English Version
Non-active surgical implants - General requirements (ISO
14630:2008)
Implants chirurgicaux non actifs - Exigences générales Nichtaktive chirurgische Implantate - Allgemeine
(ISO 14630:2008) Anforderungen (ISO 14630:2008)
This European Standard was approved by CEN on 12 January 2008.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14630:2008: E
worldwide for CEN national Members.

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EN ISO 14630:2008 (E)
Contents Page
Foreword.3
Annex ZA (informative)  Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC.4

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EN ISO 14630:2008 (E)
Foreword
This document (EN ISO 14630:2008) has been prepared by Technical Committee ISO/TC 150 "Implants for
surgery" in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat
of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by July 2008, and conflicting national standards shall be withdrawn at the
latest by July 2008.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 14630:2005.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive(s).
For relationship with EC Directive(s), see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 14630:2008 has been approved by CEN as a EN ISO 14630:2008 without any modification.
3

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EN ISO 14630:2008 (E)
Annex ZA
(informative)


Relationship between this European Standard and the Essential Requirements
of EU Directive 93/42/EEC
This International Standard has been prepared under a mandate given to CEN by the European Commission
to provide one means of conforming to Essential Requirements of the EU Directive 93/42/EEC
...